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Sarepta would need to conduct new analyses to validate the safety of Elevidys—which has had U.S. shipments paused by the ...
The European drug authority recommends refusal of marketing authorization after study shows no benefit over placebo.
Investor's Business Daily on MSN1d
The Hits Keep Coming For Sarepta. Why Its Latest Setback Creates A 'Dangerous Precedent' For Gene Therapies.Sarepta stock plunged again Thursday on a report that the Food and Drug Administration will require additional clinical ...
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After the FDA request, Cambridge, Massachusetts-based Sarepta said in a statement that it will continue to ship the therapy ...
The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.
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